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. 2016 Jun 28;2016(6):CD009034. doi: 10.1002/14651858.CD009034.pub2

Yan 2011.

Methods Multiple‐centre (Beijing, Shanghai, Wuhan and Guangzhou), prospective, randomised, controlled trial
Dates the study was conducted: not reported
Funding sources and potential conflicts of interest: no information reported
Definition of compliance: not reported
Participants Number and type of participants: 624 H.pylori‐positive participants were enrolled in the study
Participants were randomised to 2 different treatment groups: 10‐day standard triple regimen and 10‐day sequential regimen
Number of participants randomised: 622 (ITT sample)
Number of participants in the 10‐day STT arm: 281
Number of participants in the 10‐day SEQ arm: 341
PP sample: not reported
Country: China
Average age (SD) of the population in years: not reported
Sex (M/F) of the population: not reported
Authors reported that there were no differences in age or BMI between treatment groups
Medical condition at baseline: not reported
H. pylori diagnostic methods in all treatment arms: histopathology Warthin‐Starry (WS) stain and RUT
Interventions Participants randomised to the SEQ group were administered tinidazole
Length of STT (days): 10
Name, dose timing of antibiotics in 10‐day STT:
esomeprazole 20 mg twice a day + clarithromycin 500 mg twice a day + amoxicillin 1 g twice a day (during 10 days)
Name, dose timing of antibiotics in 10‐day SEQ:
esomeprazole 20 mg twice a day + amoxicillin 1 g twice a day (during 5 days) and esomeprazole 20 mg twice a day + clarithromycin 500 mg twice a day + tinidazole 500 mg twice a day (during 5 days) (Total: 10 days)
Sensitivity test (yes/no) to antibiotics before/after treatment: not reported
Method of assessment of H. pylori status both before and after treatment: ¹³C‐UBT and histology WS stain
Time for assessment of H. pylori status after treatment: 4 ‐ 12 weeks
Outcomes ITT eradication rate (%) by treatment group:
  • 10‐day STT: 220 / 293 (75.1)

  • 10‐day SEQ: 185 / 246 (75.2)


PP eradication (%) by treatment group were not reported
Metronidazole resistance (%) before treatment, SEQ ITT/PP: not reported
Metronidazole resistance (%) before treatment, STT ITT/PP: not reported
Clarithromycin resistance (%) before treatment, SEQ ITT/PP: not reported
Clarithromycin resistance (%) before treatment, STT ITT/PP: not reported
Compliance: not reported
Incidence of AEs at PP analysis in the total population: not reported
Incidence (%) serious AEs SEQ / STT: not reported
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The study was reported as "randomised", no additional information was given
Allocation concealment (selection bias) Unclear risk Risk is unclear
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Risk is unclear
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Risk is unclear
Publication format High risk Abstract